Systems and methods for providing a safety integrated catheter with universal grip

ABSTRACT

A universal gripping surface is provided on an intravenous catheter assembly. The universal gripping surface provides a plurality of surfaces whereby a user may grip the catheter assembly in a desired gripping configuration for improved balance and control of the catheter assembly during insertion of the catheter. Additionally, the universal gripping surface includes a guard feature to prevent a user&#39;s unintended contact with various components of the catheter assembly whereby the contact may result in an undesirable “over the bevel” condition.

BACKGROUND OF THE INVENTION

The current invention relates to infusion devices, specifically toover-the-needle peripheral intravenous (IV) catheters. Specifically, theinvention relates to a peripheral IV catheter assembly with a universalgripping surface and safety features. The catheter assembly includes aplurality of gripping surfaces configured to permit multiple grippingconfigurations common in the medical field. The catheter assemblyfurther includes safety features to prevent accidental exposure toblood, as well as to prevent premature separation of various componentsof the assembly. Catheters are widely used throughout the medicalcommunity for a wide range of procedures and treatments.

Catheters are commonly used for a variety of infusion therapies.Catheters are used for infusing fluid, such as normal saline solution,various medicaments, and total parenteral nutrition, into a patient,withdrawing blood from a patient, or monitoring various parameters ofthe patient's vascular system. A common type of intravenous (IV)catheter is an over-the-needle peripheral IV catheter. As its nameimplies, an over-the-needle catheter is mounted over an introducerneedle having a sharp distal tip. At least the distal portion of thecatheter tightly engages the outer surface of the needle to preventpeelback of the catheter and thus facilitate insertion of the catheterinto the blood vessel. The catheter and the introducer needle areassembled so that the tip of the introducer needle extends beyond thetip of the catheter with the bevel of the needle facing up away from thepatient's skin. The catheter and introducer needle are generallyinserted at a shallow angle through the patient's skin into a bloodvessel.

The process of placing a catheter requires careful balance and controlover the catheter. Various configurations and methods for gripping thecatheter assembly have been developed to aid the user in maintaining therequired balance and control. Among these gripping techniques are“straight grip”, “ported grip”, and “winged grip” configurations.Preferred gripping configurations vary from one market to another.Preferred gripping configurations are largely determined and establishedby local trainings, customs, and traditions. Additionally, one grippingconfiguration may be preferred or taught over another where a market isunable to obtain catheter assembly configured to permit a differentgripping configuration.

For example, a straight grip configuration may be taught out ofnecessity in a market where available catheter assemblies do not includefeatures to permit a ported grip or winged grip configuration. Thus,users in these markets must curtail their technique and skills toaccommodate the available catheter assemblies, rather than use agripping technique that best suits the user's and patient's needs.

Accordingly, there is a need in the art for a catheter assemblyincorporating a universal gripping surface that will allow users toselect the most appropriate gripping configuration. There is a furtherneed to provide a universal grip incorporating safety features to allowa user to securely grip the catheter assembly yet prevent prematureseparation of the catheter assembly components. Such a universalgripping surface is disclosed herein.

BRIEF SUMMARY OF THE INVENTION

In order to overcome the limitations discussed above, the presentinvention relates to a plurality of new gripping surfaces that provide auniversal gripping surface to accommodate various grippingconfigurations common in the medical field. The universal grippingsurface provides a single catheter assembly which allows a user to graspthe catheter assembly in either a straight grip configuration, a portedgrip configuration, or a winged grip configuration. Thus, the presentinvention may be used in any market in the world without requiringmodification or special production to meet specialized grippingconfigurations common to that market. Additionally, the present catheterassembly includes various safety features to ensure safe and efficientinsertion of the catheter.

The universal gripping surface of the current invention is designed tobe used alone or in conjunction with current, traditional grippingsurfaces and is designed to allow a “choked up” grip while preventingthe “over the bevel” condition. The catheter assembly generally includesa needle hub, a needle tip shield, and a catheter adapter, each of whichis aligned along a common axis via an introducer needle. Each componentis configured to interact and couple to an adjacent component to providean integrated apparatus. The needle hub and the catheter adapter furtherinclude various features to aid a user in gripping the catheterassembly, the combination of which forms a universal gripping surface.

Specifically, some embodiments of the catheter assembly include auniversal gripping surface having a pair of oppositely positioned gripsto accommodate opposing digits of a user. These oppositely positionedgrips are generally located on the needle hub portion of the assemblyand are pinched by the user to hold the catheter assembly in a straightgrip configuration. The oppositely positioned grips may also includefeatures, such as contours and textures, to further aid the user insecurely gripping the surfaces.

Some embodiments of the catheter assembly further include a universalgripping surface having a paddle grip. The paddle grip is an outwardextension of the needle hub that is positioned adjacent to the catheteradapter of the catheter assembly. The paddle grip is generallypositioned to occupy a space adjacent to one side of the catheteradapter. As such, a user may pinch the paddle grip and control thecatheter assembly from a winged grip configuration. The direct couplingbetween the paddle grip, the needle hub, and the introducer needleprevents an “over the bevel” condition from occurring during insertionof the catheter. In some embodiments, the paddle grip further includes aleading edge for accommodating a digit of the user to enable a port gripconfiguration.

Additionally, some embodiments include a securement platform forming aportion of the catheter adapter. The securement platform includes atleast one wing-like extension generally positioned opposite the paddlegrip. The securement platform may also include a leading edge foraccommodating a digit of the user. The leading edge of the securementplatform is used in conjunction with the leading edge of the paddlegrip, and a thumb grip forming a proximal end of the needle hub, toenable a ported grip configuration. In some embodiments of the presentinvention, the thumb grip forms a base or proximal end of the needle huband is a generally planar surface perpendicular to the oppositelypositioned grips. In some implementations of the present invention, thethumb grip further includes a contour or a texture to increase frictionbetween the needle hub and the thumb of the user.

The ported grip configuration is achieved via simultaneously contactingthe leading edge of the securement platform with a first digit,contacting the leading edge of the paddle grip with a second digit, andcontacting the thumb grip with a thumb. This three-point, ported gripconfiguration provides control and dexterity during insertion, as wellas provides a bridging effect to prevent premature separation of theindividual components of the catheter assembly, or an “over the bevel”condition.

Some embodiments of the present invention further include a guardfeature. The guard feature is located on an outer surface of the needlehub of the catheter assembly, so as to be interposed between theoppositely positioned gripping surfaces and the catheter adapter.Specifically, the oppositely positioned gripping surfaces may include aguard feature whereby a portion of the gripping surfaces is extendedoutwardly thereby preventing a user's finger and thumb frominadvertently contacting a portion of the catheter assembly. The guardfeature is provide as a physical barrier to permit a user to grasp theassembly in a straight grip configuration, yet prevent the user frominadvertently contacting the needle tip shield or catheter adaptercomponents of the assembly. Inadvertent contact may result in prematureseparation of the components leading to an “over the bevel” condition.Thus, the guard feature prevents the occurrence of this condition.

In some implementations of the present invention, the needle tip shieldcomprises a safety feature or other device for retaining the tip of theintroducer needle following insertion of the catheter. The needle hubgenerally includes a shield hub for receiving and housing a portion ofthe needle tip shield within an interior of the needle hub. The needleshield may further include a handle or grip to assist a user inimmobilizing the needle tip shield and the catheter adapter duringremoval of the introducer needle from the catheter and catheter adapter.The needle tip shield may also include a feature for interlocking theneedle tip shield and the catheter adapter to prevent prematureseparation.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1 is a perspective view of an embodiment of the present invention.

FIG. 2 is an exploded perspective view of FIG. 1.

FIG. 3A is a perspective top view of an embodiment of the presentinvention held in a straight grip configuration.

FIG. 3B is a perspective top view of an embodiment of the presentinvention held in a ported grip configuration.

FIG. 3C is a perspective top view of an embodiment of the presentinvention held in a winged grip configuration.

FIG. 4 is a perspective top view of an embodiment of the presentinvention without a securement platform.

FIG. 5 is a perspective top view of an embodiment of the presentinvention without a securement platform or a paddle grip.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiment of the present invention will be bestunderstood by reference to the drawings, wherein like reference numbersindicate identical or functionally similar elements. It will be readilyunderstood that the components of the present invention, as generallydescribed and illustrated in the figures herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description, as represented in the figures, isnot intended to limit the scope of the invention as claimed, but ismerely representative of presently preferred embodiments of theinvention.

Referring now to FIG. 1, a catheter assembly 10 is illustrated includinga needle hub 12, a needle tip shield 14, and a catheter adapter 16. Eachof the components 12, 14, and 16 of the catheter assembly 10 isconfigured so as to cooperate as an integrated apparatus. Thus, eachcomponent 12, 14, and 16 comprises features and elements to permitcompatible engagement with an adjacent component.

For example, in one embodiment of the present invention the needle hub12 comprises a shield hub 18 for receiving and docking a proximalportion 46 of the needle tip shield 14. Additionally, a distal end 48 ofthe needle tip shield 14 is configured to compatibly receive a proximalend 50 of the catheter adapter 16. Each of the components 12, 14, and 16are aligned and coordinated via an introducer needle 66 which extendsfrom the needle hub 12, through central lumens of the needle tip shield14 and the catheter adapter 16 to provide an integrated apparatus 10, asmore clearly seen in FIG. 2 below.

The needle hub 12 further includes a plurality of surfaces and featuresto assist a user in grasping the catheter assembly 10 during insertionprocedures. For example, in some embodiments of the present inventionthe needle hub 12 comprises a distal extension forming a paddle grip 30.The paddle grip 30 comprises a rigid or semi-flexible extension of theneedle hub 12 having upper and lower gripping surfaces 32 and 34,respectfully. The paddle grip 30 is positioned adjacent to the bodyportion 60 of the catheter adapter 16 in a parallel orientation. In someembodiments, the paddle grip 30 occupies a space directly opposite asecurement platform 62 of the catheter adapter 16. The upper 32 andlower 34 gripping surfaces of the paddle grip 30 are configured toaccommodate opposing digits of a user, as shown in FIG. 3C. As such, thepaddle grip 30 enables a user to grasp the catheter assembly 10 in awinged grip configuration.

In some implementations of the present invention, the needle hub 12further includes a first gripping surface 22 and a second grippingsurface 24. The first and second gripping surfaces 22 and 24 compriseparallel, opposing surfaces of the needle hub body 20. As configured,the gripping surfaces 22 and 24 permit a user to grasp the catheterassembly 10 in a straight grip configuration, as shown in FIG. 3A. Insome embodiments, the gripping surfaces 22 and 24 are contoured tofurther accommodate the physiological shape of the user's opposingdigits. In other embodiments, the gripping surfaces 22 and 24 furtherinclude a texture or anti-slip coating 36 to increase friction betweenthe user's digits and the needle hub 12. Still further, in someembodiments the gripping surfaces 22 and 24 comprise multiple contoursto provide an ergonomic gripping surface.

The gripping surfaces 22 and 24 may further include a guard feature 40.The guard feature 40 generally comprises an outwardly extended portionof the gripping surface 22 and 24 which provides a physical barrierbetween the user's opposing digits and the remaining components 14 and16 of the catheter assembly 10. In some embodiments, one or moregripping surfaces 22 and/or 24 comprise an outward, exponential curve42, wherein the peak 44 of the curve 42 is the guard feature 40. Inother embodiments, the guard feature 40 comprises any physical barrierto prevent the user's grip from extending beyond the needle hub 12 tocontact the needle tip shield 14 or the catheter adapter 16. In someimplementations of the present invention, a guard feature 40 isinterposed between the body portion 20 of the needle hub 12, and thepaddle grip 30.

Finally, in some implementations of the present invention the needle hub12 further includes a thumb grip 26. The thumb grip 26 comprises theproximal end 28 of the needle hub 12 and provides a generally flatsurface to accommodate a user's thumb. In some implementations of thepresent invention, the thumb grip 26 further includes a texture oranti-slip coating 36 to increase friction between the user's thumb andthe needle hub 12. In some embodiments, the thumb grip 26 furtherincludes a contoured surface to provide an ergonomic gripping surface.

The thumb grip 26 is generally used in conjunction with a leading edge52 of the paddle grip 30, and a leading edge 54 of the securementplatform 62 to enable a user to grasp the catheter assembly 10 in aported grip configuration, as shown in FIG. 3B. In some embodiments, theleading edge 52 of the paddle grip 30 is contacted with a first digit,such as an index finger, the leading edge 54 of the securement platform62 is contacted with a second digit, such as a middle finger, and thethumb grip 26 is contacted with the thumb of the user.

The multiple contact points 52, 54, and 26 of the ported gripconfiguration not only provides control, but also provides a bridgingeffect to prevent premature separation of the various components 12, 14,and 16 of the catheter assembly during insertion procedures. Prematureseparation of the components 12, 14, and 16 may lead to an “over thebevel” condition. The “over the bevel” condition occurs where thebeveled portion 68 of the introducer needle 66 is withdrawn into thecatheter 70 prior to the beveled portion 68 providing a sufficientopening in the patient for insertion of the catheter 70. This conditionis often painful for the patient and may result in failed insertion, aswell as various other undesirable complications. Thus, the varioussurfaces and features of the present invention provide a catheterassembly 10 having universal gripping surfaces which allow for multiplemethods of gripping the catheter assembly 10, while preventing the “overthe bevel” condition.

Referring now to FIG. 2, an exploded view of the catheter assembly 10 isshown. The individual components 12, 14, and 16 are generally alignedalong a longitudinal axis 80. The introducer needle 66 generallycomprises a first end (not shown) fixedly attached to the needle hub 12,and a free end 72 extending outward therefrom. The free end 72 of theintroducer needle comprises the beveled portion 68 and a needle tip forproviding an opening in the patient through which the catheter 70 isinserted. In some embodiments, the needle tip shield 14 comprises afeature for engaging and retaining the needle tip within the needle tipshield 14 following insertion of the catheter 70. Thus, once thecatheter 70 has been inserted and the introducer needle 66 has beenremoved from the catheter 70, the tip of the introducer needle 66 isretained in the needle tip shield 14 to prevent accidental exposure tothe needle tip and fluids therein. The catheter adapter 16 may alsoinclude a fluid line 74, or intravenous tubing for providing a fluid ormedicament to the patient via the catheter 70. In some implementationsof the present invention, the needle tip shield 14 further includes aclip or pawl (not shown) for retaining the proximal end 50 of thecatheter adapter 16. In these embodiments, the clip or pawl preventsseparation of the needle tip shield 14 from the catheter adapter 16until after the needle tip has been secured within the needle tip shield14.

The needle hub 12 may further include design features to accommodatefeatures of adjacent components 14 and 16. For example, in someembodiments the distal end 38 of the needle hub body 20 includes arecessed surface 56 to accommodate a grip feature 90 of the needle tipshield 14. In another embodiment, a portion of the distal end 38 of theneedle hub body 20 is beveled to provide clearance for the fluid line 74of the catheter adapter 16.

Referring now to FIG. 3A, an implementation of the present invention isshown as held in a straight grip configuration. As shown, the first andsecond gripping surfaces 22 and 24 provide opposing surfaces toaccommodate opposing digits 100 and 102 of a user. In some embodimentsof the present invention, a thumb 100 of a user engages the firstgripping surface 22 and an index finger 102 of a user engages the secondgripping surface 24. In this manner, the user pinches the opposedgripping surfaces 22 and 24 of the needle hub 12 to grasp the catheterassembly 10. In some embodiments, the user grip is shifted distallytowards the catheter adapter 16 into a “choked up” position. When heldin a “choked up” position, the user's opposing digits 100 and 102largely occupy or contact the guard feature 40 of the gripping surfaces22 and 24. The “choked up” position may be desirable to provideincreased control and leverage during insertion procedures. The presenceof the guard features 40 permit the “choked up” position, yet preventinadvertent contact between the user's digits 100 and 102, and theremaining components 14 and 16 of the catheter assembly 10.

Referring now to FIG. 3B, an implementation of the present invention isshown as held in a ported grip configuration. As shown, the ported gripconfiguration utilizes three-points of contact to grasp the catheterassembly 10. A thumb grip 26 provides a first point of contact, and isconfigured to receive a first digit of a user, for example a thumb 100.A leading edge 54 of the securement platform 62 provides a second pointof contact, and is configured to receive a second digit of a user, forexample an index finger 102. A leading edge 52 of the paddle grip 30provides a third point of contact, and is configured to receive a thirddigit of a user, for example a middle finger 104. In this manner, theuser contacts all three points 26, 52, and 54 to grasp the catheterassembly 10.

Referring now to FIG. 3C, an implementation of the present invention isshown as held in a winged grip configuration. As shown, the winged gripconfiguration is aided by the paddle grip 30. The paddle grip 30 is arigid or semi-flexible extension of the distal end 38 of the needle hub12. The paddle grip 30 includes a generally planar surface having afirst side and a second side, wherein the first side comprises an uppersurface 32 and the second side comprises a lower surface 34. The paddlegrip 30 is gripped by placing a first digit, such as a thumb 100, on theupper surface 32, and placing a second digit, such as an index finger102, on the lower surface 34. As such, the opposing digits 100 and 102pinch the paddle grip 30 to secure the catheter assembly 10. Thus, someimplementations of the catheter assembly 10 of the present inventioncomprise multiple surfaces and features to permit various methods ofgripping the catheter assembly 10.

Referring now to FIG. 4, an implementation of a catheter assembly 200 isshown. Some embodiments of the present invention may be modified tolimit the methods of gripping the catheter assembly 10. For example,catheter assembly 200 has been modified to accommodate only straightgrip, and winged grip configurations. Specifically, the catheter adapter160 has been modified to exclude securement platform 62 of catheteradapter 16, as shown in FIGS. 1-3C, above. By removing securementplatform 62, the catheter assembly 200 eliminates the possibility of aported grip configuration. Modifications such as these may be desirablefor markets or industries where one or two grip configurations aredesirable, or more common than another. Modifications such as these mayalso reduce manufacturing costs, as well as eliminate unnecessaryfeatures for a given market. In some embodiments, catheter assembly 200is further modified by removing the paddle grip 30, thereby selectivelylimiting possible insertion methods of the catheter 60 to a straightgrip configuration, as shown in FIG. 5.

The present invention provides a safety integrated catheter assemblyhaving universal gripping surfaces. The present invention furtherpermits a user to grasp the catheter assembly in a variety of grippingpositions without the possibility of creating an “over the bevel”condition. Accordingly, the present invention is adapted to provide auseful, safe, and universal gripping surface for balanced, controlledhandling of catheter assemblies during insertion of a catheter. Thepresent invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments are to be considered in all respects only asillustrative, and not restrictive. The scope of the invention is,therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

1-15. (canceled)
 16. An intravenous catheter device, comprising: acatheter adapter having a first end and a second end, the first endsupporting a catheter; a needle tip shield having a first end and asecond end, the first end removably coupled to the second end of thecatheter adapter; and a needle hub having a first end, a second end, anda middle portion, the first end being removably coupled to the secondend of the needle tip shield, the middle portion including a grippingsurface for accommodating opposing digits to enable a straight grip ofthe catheter device, and the second end including an end surface foraccommodating a thumb, the first end of the needle hub further includingan outwardly protruded guard feature interposed between the grippingsurface and the needle tip shield, the second end of the needle hubfurther including a needle fixedly attached to the second end andextending outwardly therefrom such that the needle intersects, aligns,and coordinates the needle tip shield, the catheter adapter and thecatheter to provide an integrated catheter device.
 17. The catheterdevice of claim 16, wherein the first end of the needle hub furthercomprises a paddle grip extending outwardly therefrom, the paddle griphaving a top surface and a bottom surface, the top surface configured toaccommodate a thumb, and the bottom surface configured to accommodate anopposing digit whereby the paddle grip is pinched between the thumb andthe opposing digit to enable a winged grip of the catheter apparatus.18. The catheter device of claim 16, further comprising a catheteradapter catch occupying a portion of the second end of the catheteradapter, wherein the catheter adapter catch is secured within the firstend of the needle tip shield thereby interlocking the needle tip shieldand the catheter adapter prior to removal of the needle from thecatheter adapter.
 19. The catheter device of claim 16, wherein the guardfeature provides a barrier between the opposing digits and needle tipshield.
 20. The catheter device of claim 16, further comprising anexponentially curved surface interposed between the guard feature andthe gripping surface.
 21. The catheter device of claim 20, wherein aportion of the exponentially curved surface is the gripping surface. 22.The catheter device of claim 16, wherein the guard feature comprises aportion of the gripping surface.
 23. The catheter device of claim 16,further comprising a securement platform extending laterally outwardfrom the catheter adapter, the securement platform having a firstleading edge and a second leading edge, wherein the first leading edgeis configured to accommodate a first digit, the second leading edge isconfigured to accommodate a second digit, and the end surface isconfigured to accommodate the thumb to enable a ported grip of thecatheter device, and wherein a top surface and a bottom surface of thesecurement platform is further configured to accommodate opposing digitsto enable a winged grip of the catheter device.
 24. The catheter deviceof claim 23, wherein the guard feature is interposed between thegripping surface and the securement platform.
 25. The catheter device ofclaim 16, further comprising: a securement platform occupying a firstside of the catheter adapter, the securement platform having a planarsurface in a first plane that is generally perpendicular to the grippingsurface of the needle hub middle portion; and a paddle grip extendingoutwardly from the first end of the needle hub, the paddle grip beingposition adjacent to the catheter adapter and opposite the securementplatform, the paddle grip having a planar surface in a second plane thatis generally parallel to the first plane.
 26. The catheter device ofclaim 25, wherein a first portion of the guard feature is interposedbetween the gripping surface and the securement platform, and a secondportion of the guard feature is interposed between the gripping surfaceand the paddle grip.
 27. The catheter device of claim 25, wherein adistal edge of the securement platform comprises a first leading edge tosupport a first digit, and a distal edge of the paddle grip comprises asecond leading edge to support a second digit, wherein the first leadingedge, the second leading edge and the end surface are contacted with thefirst digit, the second digit and the thumb, respectively, to enable aported grip of the catheter device.